1Material selection

A sterile barrier system must let the sterilant in, keep microorganisms out, and allow aseptic opening. For steam, EO and formaldehyde, paper/film pouches and reels (medical-grade 60–70 g/m² paper with a CPP/PET film) are the standard choice. For hydrogen peroxide plasma, use Tyvek® or polypropylene non-woven. Confirm that the manufacturer states conformity with ISO 11607-1 and EN 868-5 and can provide test reports.

2Sizing and loading

  • Choose a pouch or cut a reel length that leaves at least 30 mm between the instrument and each seal.
  • Fill pouches to no more than three-quarters of their volume; use gusseted reels for bulky sets.
  • Place ring handles and hinged instruments open; point sharp tips away from the peel side and protect them with tip guards.
  • Do not double-pouch unless the inner pouch is not folded and both are validated for the purpose.

3Sealing

Heat seals should be continuous, at least 6 mm wide, with no channels, wrinkles or burn marks. Validate sealer temperature, pressure and speed for the material, and run a seal test regularly. Self-seal pouches must be folded along the perforation and pressed along the full length of the adhesive strip.

4Labelling

Write on the film side of the pouch, outside the seal, or on the indicator tape — never on the paper, which is the microbial barrier. Record contents, sterilization date, sterilizer and cycle number, and operator.

5Drying and cooling

Packs must be completely dry before they are touched. A wet pack wicks microorganisms through the paper and must be reprocessed. Allow packs to cool on the sterilizer cart in a draught-free area before moving them to storage.

6Storage and shelf life

Store below 25 °C and below 60 % relative humidity, in closed cupboards or covered shelving at least 25 cm from the floor and away from sinks and vents. Shelf life is event-related: a pack remains sterile until an event compromises it — a torn or wet pack, a broken seal, crushing or excessive handling. Kangde Med recommends a validity of six months after sterilization under these conditions, with a visual inspection of every pack before it is opened.

7Conclusion

Most sterility failures do not happen in the sterilizer; they happen at the packing table, the sealer and the storage shelf. Standardising materials, sizes and procedures — and training every member of the team on them — is the most effective investment a department can make.

8Frequently asked questions

Can I reuse a sterilization pouch?

No. Pouches and reels are single-use. The paper barrier and seals are not designed to withstand a second cycle.

Why must I not write on the paper side?

Ink and pen pressure can damage the porous paper, creating a path for microorganisms and compromising the sterile barrier.